Combination syringe and vial container



July 16, 1968 G. L. POCHYLA ET Al COMBINATION SYRINGE AND VIAL CONTAINERFiled AugA 9. 1965 M, l 7 4 4 1J du f 243 3% W| il Yi@ l 0/ .d f W a W 04 2 9 9 5M, 4

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am /af M Mw wf United States Patent O 3,392,726 COMBINATION SYRINGE AND.VIAL CONTAINER Gerald L. Pochyla and' William R. Smith, Kalamazoo,Mich., assignors to The Upjohn Company, Kalamazoo, Mich., a corporationof Delaware Filed Aug. 9, 1965, Ser. No. 478,085

7 Claims.` (Cl. 12S- 272) ABSTRACT OF THE DISCLOSURE A combinedcontainer and injection device comprising a vial defining a mixingchamber for a first sterile ingredient and a syringe connected to thevial and defining a storage chamber for a second sterile ingredient. rApenetrable plug is inserted into the open end of the vial and aliquid-tight connector extends between the plug and the discharge end ofthe syringe. The connector supports a cannula having its lower endextending through the plug into the vial and its upper end embedded inthe seal, which the cannula can be caused to penetrate.

This invention relates in general to a combined multiple-compartmentcontainer and injection `device and, more particularly, to a typethereof having separate compartments in which two or more ingredientsmay be maintained independent of each other until it is desirable tocombine them, after which the two compartments can be quickly and easilyplaced in communication with each other by a connecting mechanismwhichincludes the injection device.

Particularly in the packaging of pharmaceuticals or medicaments, it isfrequently necessary or desirable to provide a unitary container inwhich two or rnore ingredients are placed and maintained completelyseparate until the use of the combined ingredients is required. As aWell-known example, some fluids, which are injected into human or animalbodies, comprise a mixture of dry powdered ingredients and areconstituting diluent, which mixture loses its strength or otherwisebecomes unacceptable after a relatively short time has elapsed. Thus,much attention has been given for many years to the development of acompletely satisfactory two-compartment package or container for thepharmaceutical industry. However, existing two-compartment packagescapable of use for storing the ingredients and thereafter injecting theminto the human lbody have proved unsuccessful and/or unacceptable forone or ymore of a variety of reasons, which the containers of thisinvention are designed to overcome.

While the descriptive material contained in this application is directedprimarly to the disclosure of a combined two-compartment container andinjection device adapted for use in the medical field, it will berecognized that such a device may prove useful in other unrelatedfields.

Accordingly, a pri-mary object of this invention has been the provisionof a combined multiple-compartment container and injection device whichis simple in construction, economical to fabricate, relatively easy tofill, and comprised of components with which the user, such as aphysician, is already familiar, so that the ingredients can be mixedquickly, as in the case of an emergency, without time-consuming reectionupon the mechanics of operating the device.

A further object ofthe invention has been the provision of a device, asaforesaid, comprised `of a syringe and a vial with connector means whichis a departure from structures of the prior art, which provides a lesscostly and more easily operable mechanism for effecting inter- 3,392,726Patented July 16, 1968 ICC connection and communication between thesyringe and the vial without risk of contaminating the separated sterileingredients prior to or `during the .mixing operation, and which permitseasy use of the syringe to inject the mixture in a conventional manner.

Other objects and purposes of the invention will become apparent topersons familiar with this type of equipment upon reading the followingdescriptive material and examining the accompanying drawings, in which:

FIGURE 1 is a partially sectioned, side. elevational view of a containerembodying the invention.

FIGURE 2 is a broken, sectional View substantially as taken along theline II-II in FIGURE l.

FIGURE 3 is a sectional view similar to FIGURE 2 showing parts thereofin different positions of operation.

FIGURE 4 is a sectional view taken along the line IV-IV in FIGURE 2.

FIGURE 5 is an enlarged fragment of FIGURE l with part of the connectorbroken away to show the seal.

FIGURE 6 is a sectional view similar to that shown in FIGURE 2 anddisclosing a modified structure.

For convenience in description, the terms upper, lower and words ofsimilar import will have reference to the device of the invention asappearing in FIGURE l. The terms innen outer and words of similar importwill have reference to the central vertical axis of the device asappearing in FIGURE l.

GENERAL CONSTRUCTION The device of this invention essentially comprisesa vial containing a mixing chamber in which a first sterile ingredient,such as a dried powder, is placed during the filling operation. Asyringe having a storage chamber is attached to the vial by a connector,and a second sterile ingredient, such as a uid diluent, is placed in thestorage chamber during the filling operation, A penetrable, preferablyresiliently flexible, plug is inserted into the upper open end of thevial for sealing the mixing chamber. The substantially tubular connectoris attached to and extends substantially coaxially between the stopperand the lower discharge end of the syringe. The connector includes anupper tubular member containing a liquid-tight seal, which covers thelower open end of the syringe barrel, and also includes a lower tubularmember which is telescopically attached to the upper tubular member andis slideably and snugly received into a recess in the stopper. A cannulaor needle is rigidly mounted upon and extends coaxially through thelower tubular member and through the lower part of the stopper. Theupper end of the needle is embedded in the seal in the upper tubularmember.

By -moving the tubular members toward each other, tbe needle is causedto penetrate the seal and thereby provide communication between themixing and storage chambers. However, prior to such penetration, theingredients in the two chambers are maintained completely separate fromeach other by substantially vapor-resistant seals. After the upper sealis perforated by the cannula, the syringe plunger is moved downwardlyinto the storage chamber whereby the diluent is forced through thecannula into the mixing chamber, whereby the combined dil-uent andserile powder, for example, can be combined byshaking the entire device.Thereafter, the contents of the -mixing chamber can be withdrawn. -bymoving the plunger away from the vial, after which the syringe can beremoved from the vial for use in perfor-ming an injection in asubstantially conventional manner.

DETAILED DESCRIPTION As shown in FIGURE 1, which illustrates a preferredembodiment of the invention, the combined container and injection deviceof the invention is comprised of a vial 11 having a stopper 12 in itsupper open end, a syringe 131 having a barrel 14, and a connector 17between the barrel 14 and the stopper 12. The syringe 13 has an openupper end through which a plunger 18 extends for manual engagement atits upper end. A piston 19 is connected to the lower end of the plunger18 and defines the upper limits of the storage chamber 22 in which aliquid diluent 23, for example, is contained. The piston 19 ispreferably fabricated from a material, such as a lbutyl rubber, which issubstantially impervious to the transference of moisture or vaportherethrough and which will maintain a tight seal with the inside wallsof the barrel 14.

The syringe 13 may be of a substantially conventional construction,providing only that the barrel 14 has a lower end portion 24 (FIGURES 1and 2) of reduced diameter with a radially outwardly extending bead 26along its lower edge for reasons appearing hereinafter. The syringe maybe fabricated from glass, plastic or the like. The vial 11 may also besubstantially conventional in that it has a neck portion 27 at its upperend defining an opening 28 into which the stopper 12 is inserted. Inthis particular embodiment, the wall of the neck portion 27 defining theopening 28 is snugly engaged by annular ridges 32 on the side wall ofthe stopper 12, and the sidewardly extending, integral fiange 33adjacent the upper end of the stopper 12 is in snug engagement with theupper edge of the neck portion 27.

Said stopper 12 has a preferably coaxial and upwardly opening recess 34which provides a relatively thin, but liquid and vapor-tight end wall 36between said recess 34 and the mixing chamber 37, the upper limits ofwhich are defined by the lower surface 38 of the stopper 12. The depthof the recess 34 is governed largely by the desired thickness of thepenetrable wall 36 and the amount of rigidity which must be provided bythe stopper in the support of the connector 17. In this particularembodiment, the stopper 12 is preferably made from butyl rubber whichmay include additives of various known types and which has thewell-known quality of being highly resistant to the transference ofliquids, vapors or gases therethrough or therearound. An overseal 40,which may be metallic, rigidly secures the stopper 12 upon the neck 27of the vial 11 in a conventional manner.

The connector 17 is comprised of an upper tubular member 39 which ispreferably of circular cross section and has a lower end portion 42 ofreduced diameter, which provides a radially disposed wall or shoulder43. The upper end of the tubular member 39 is snugly sleeved upon thelower end portion 24 of the barrel 14 and the upper edge 44 of saidtubular member is bent yradially inwardly in any convenient manneraround the bead 26 to prevent disengagement therebetween.

A sealing member 46 is snugly disposed between the lower edge of the endportion 24 and the shoulder 43 and is preferably held under slightcompression therebetween, so that it seals the opening in said endportion 24. The peripheral surface 47 of the sealing member 46 ispreferably concave, whereby, as shown in FIGURE 5, a pair of radiallyoutwardly projecting ridges 48 and 49 are provided on the peripheralsurface 47 adjacent the upper and lower edges thereof. Said ridges 48and 49 may or may not engage the inner wall of the tubular member 39. Asshown in FIGURES 2 and 3, the open space or Zone 52 between the surface47 and the adjacent surface of the tubular member 39 is reduced byeither partial or complete penetration of the sealing member 46 by thecannula or needle 53. Thus, the zone 52 provides for the expansion ofthe sealing member 46 as it is penetrated by the needle 53.

,The connector 17 also includes a lower tubular member 56 having anupper sleeve portion 57 which is telescopically engaged with the lowerend portion 42 of the tubular member 39. In this particular embodiment,the sleeve portion 57 is on the outside of the end portion 42, 'but thisarrangement could be reversed. The tubular member 56 has a lower endportion of reduced inside diameter in which the cannula 53 is snugly andfirmly held by means of the sleeve 58 through which the cannula extendsaxially. The outside diameter of the tubular member 56 is preferablyslightly larger than the minimum inside diameter of the recess 34 in thestopper 12 so that said tubular member 56 can be snugly received intosaid recess 34 and, accordingly, firmly held with respect to saidstopper 12. The radial wall o-f the recess 34 may be provided withannular, radially inwardly extending ridges 61 for the purpose ofproviding a more readily releasable grip, but equally firm positioning,of the tubular member 56 by said stopper 12 within the recess 34.

The lower end portion 42 of the tubular member 39 has an annular,outwardly opening groove 62 which may be formed by a pair of spacedannular ridges 63. The inner surface of the sleeve portion 57 of thetubular member 56 is provided with a radially inwardly extending,annular ridge 64 which has an inside diameter preferably of about thesame diameter as the groove 62 into which the ridge 64 can be urged whenthe sleeve portion 57 is telescoped with the lower end portion 42 toyieldably oppose relative axial movement therebetween.

The cannula 53 is mounted within the tubular member 56 so that, as shownin FIGURE 2, its upper end is embedded in, but does not extend through,the sealing member 46 when the ridge 64 is within the groove 62.However, lby urging the vial 11 upwardly toward the radial wall 43, theridge 64 can be manually displaced from within the groove 62 so that theupper edge of the sleeve portion 57 bears against said wall 413 and, atthe same time, the upper end 66 of the cannula 53 passes through thesealing member 46 so that its passageway 67 can communicate with thestorage chamber 22. When such insertion is completed, the opening at theupper end of the cannula 53 is closely adjacent the upper surface of thesealing member 46.

Operation It is probably evident from the foregoing descriptive materialthat the syringe 33 may be inverted and filled with a sterileingredient, such as a liquid diluent, through its opening 25 in asubstantially conventional manner after the plunger 18 has been insertedinto the upper end thereof. The sealing member 46 is then assembled uponthe end portion 24 of the barrel 14 so that the contents of the syringe13 are now confined within a liquid-tight and substantially vapor-proofstorage chamber 22 where they are ready for use and protected fromcontamination.

A sterile ingredient, such as a dry powder, is placed in the vial 11after -which the stopper 12 is inserted Itherein and the overseal 40 issecured in place. The lower tubular member 56 is then mounted upon thestopper 12 so that the cannula 53 pierces the wall 36 in the stopper 12and extends into the mixing chamber 37, and so that the lower end of thetubular lmember 56 is firmly seated within the recess 34 in said stopper12. The syringe 13 is then mounted upon the vial 11 by inserting thelower end 0f the tubular member 39 into the sleeve portion Iof the lowertubular member 56 until the ridge 64 is disposed within the groove 62,whereby the upper end of the cannula 53 will be embedded in the sealingmember 46, as shown in FIGURE 2. The entire container device 10, being`thus assembled, can now be stored as safely as though the twoingredients involved were placed in separate containers having nointerconnection whatsoever.

The annular ridges 32 on the stopper 12 permit more.

variation in sizes and provide room for expansion of the stopper whenthe syringe is inserted thereinto.

When it becomes desirable to inject the ingredients of the container andinjection device, it is only necessary to urge the syringe 13 and vial11 toward each other until the upper end of the lower tubular member 56engages the wall 43, whereupon the upper end of the cannula 53 willpierce the sealing member 46, as shown in FIGURE 3;'Thereafter, byurging the plunger 18 downwardly, the diluent in the storage chamber 22is urged through the cannula 53 into the mixing chamber 37` wherein thedry powdered ingredient in -the vial can be reconstituted in asubstantially conventional manner. The syringe, with the tubular member56 attached thereto, ismoved away from the vial 11 in a substantiallyconventional manner until the lower end of the cannula 53 is adjacentthe lower surface 38 of the stopper 12. The container device is theninverted so that the liquiiied contents of the mixing chamber 37 can bewithdrawn therefrom into the storage chamber 22 by downward movement ofthe plunger 18. The syringe with the tubular member 56 attachedcan nowbe used in a conventional manner to inject into a human or animal bodythe contents of the syringe 13.

Alternate construction The alternate container device 71, shown inFIGURE 6, is substantially the same as the container device 10 exceptfor the structure ofthe lower tubular member 56A, the -upper tubularmember 39A and the sealing member 46A. The sealing member 46A within theupper tubular member has a substantially cylindrical stem 72 whichextends into the opening 73 defined by Ithe lower end portion 24 of thebarrel 14, so that .the thickness of the liange 74 on said sealingmember 46A between the lower edge of the end portion 24 and the radialwall 43A may be somewhat less than the corresponding distance in thecontainer device 10. The peripheral w-all 76 of the stem 72 ispreferably made concave to allow for radial displacement of a portion ofthe material within the stem 72 when the cannula 53 is urgedtherethrough.

The lower end portion 42A of the tubular member 39A is provided with apair of radially outwardly projecting, annular ridges 77 and 78 whichare spaced predetermined distances from each other and from the radialwall 43A. lEach of the ridges 77 and 78 preferably has a radiallydisposed upper surface 79 and a downwardly converging lower surface 80.

The sleeve portion 57A of the lower tubular member 56A has a radiallyinwardly projecting, annular ridge 83 preferably near the upper endthereof. Said ridge 83 has a substantially radially disposed lowersurface 84 which is engageable with the upper surfaces 79 on the ridges77 and 78 when the sleeve portion 57A is telescopically mounted upon thelower end portion 42A of the tubular member 39A. The ridges 77 and 78and the ridge 83 are :located upon their respective tubular members sothat when the lower surface 84 is engaged with the upper surface of theridge 78, the upper end of the cannula 53 will be embedded in, but willnot penetrate, the stopper 12A. However, when the lower surface 84 isengaged with the upper surface of the ridge 77, the upper end of thecannula will extend through the stopper 12A and be in communication withthe storage chamber 22. Otherwise, the assembly and operation ofthealternate container 4device 71 will be substantially the same as thatdisclosed above with respect to the container device 10.

The wall of the neck portion 27A defining the opening 86 (FIGURE 6) maybe provided with coaxial annular recesses 87 into which thecorresponding annular ridges 88 are snugly but removable received whenthe flange 33A of the stopper 12A is against the upper edge of the neckportion 27A.

The container device 10, or the alternate device 71, may be sealed in asuitable package, such as a plastic bubble on cai-dboard, to protect thedevice during storage and/ or shipment.

Although particular preferred embodiments of the invention have beendisclosed above for illustrative purposes, it will be understood thatvariations or modifications thereof, which do not depart from the scopeof the appended claims, are fully contemplated. v

The embodiments of the invention in which an exclusive property orprivilege is claimed are defined as follows:

1. A device for containing sterile ingredients for injection,comprising:

first means delinin-g a mixing chamber for containing a firstingredient;

second means defining a storage chamber for containing a uid ingredient,said first and secondmeans having openings therein communicating withtheir respective chambers;

penetrable plug means sealing the opening in said first means and havingan outwardly opening recess;

first tubular meansaixed to said second means foi a liquid-tightconnection with the opening therein, said iirst tubular means includinga seal tightly'closing `said opening in said second means;

second tubular means telescopically engaged with said lirst tubularmeans and axially movable lengthwise thereof, said second tubular meansbeing snugly received into and releasably held in said recess -forsupport of said second tubular means by said plug means, said first andsecond tubular means remaining telescopically engaged when said secondtubular means is released from said plug means;

a cannula mounted in and extending substantially coaxially through saidsecond tubular means, one end of said cannula extending substantiallycoaxially into saidv first tubular means so that the tip thereof isembedded in said seal to occupy a storage position, said second tubularmeans and said cannula being adapted for axial movement with respect tosaid rst tubular means so that said tip of said cannula pierces saidseal 'and said one end communicates with said storage chamber to occupya use position; and

plungermeans in said storage chamber -for moving the fluid ingredienttherein through said cannula after said seal is pierced thereby.

2. A device according to claim lwherein the peripheral wall of said sealmeans is concave whereby the central portion of said seal means isspaced from said second tubular member.

3. A device according to claim 1, wherein the other end of said cannulapenetrates said plug means and is in communication with the mixingchamber when in sai-d storage position.

4. A device according to claim 1, wherein said first and second tubularmeans have positive interitting lock means therebetween for releasablyresisting relative axial movement thereof whereby said cannula is movedbetween said storage position an-d said use position.

5. The device of claim 1, wherein said irst and second tubular meanshave interengageable, first and second stop means for releasably holdingsaid tubular means against relative axial movement when said cannula isin said storage position and said use position, respectively, theholding being more forceful in a direction opposed to the axialseparation of said tubular means.

6. A device according to claim 1, wherein said first tubular means has aportion of reduced diameter with a pair of spaced and annular ridgesprojecting outwardly therefrom; and

wherein said second tub-ular means is sleeved over said portion ofreduced diameter and has an annular, inwardly projecting ridge removablyreceivable between said pair of ridges when said cannula is in saidstorage position for releasably resisting relative axial movementbetween said lirst and second tubular means.

7. A device for containing sterile ingredients for injection,comprising:

first means defining a mixing chamber for containing a first ingredient;

second means defining a storage chamber for containing a secondingredient, said first and second means having openings thereincommunicating with their respective cham'bers;

penetra-ble plug means sealing the opening of said first means andhaving an outwardly opening recess;

first tubular means fixed to said second means and having a tightsealing connection with the opening therein;

seal means tightly closing said opening in said second means;

second tubular means telescopically engaged with said first tubularmeans and axially movable lengthwise thereof, said second tubular meansbeing snugly received into and releasably held in said recess forsupport of said second tubular means by said plug means, said first andsecond tubular means remaining telescopically engaged when said secondtubular means is released from said plug means;

a cannula mounted in and extending substantially coaxial'ly throughsai-d second tubular means, one end of said cannula extending into saidfirst tubular means so that the tip thereof is embedded in said seal andthe other end of said cannula extending through said plug means and`being in communication with `said mixing chamber when said cannula isin Va storage position, said second tubular means and saidcannufla beingadapted for axial movement with respect to said first tubular means sothat said tip Iof said cannula penetrates said seal and communicateswith said storage chamber when in a use position; and plunger means insaid storage chamber for moving the second ingredient therein throughsaid cannula after it penetrates said seal.

References Cited UNITED STATES PATENTS 2,724,383 11/1955 Lockhart128-215 2,742,041 4/ 1956 Lipari 128-21 2,922,419 1/ 1960 Bednarz.

3,336,924 8/ 1967 Sarnoff et al 1285-272 FOREIGN PATENTS 1,063,341 8/1959 Germany.

D. L. TRULUCK, Examiner.

